QC Technical Specialist

Job Description

QC Technical Specialist

Key Roles/Responsibilities:

• Helps maintain all QC Lab equipment in proper operational state, calibrated and qualified to include the equipment operating software packages.
• Perform a wide variety of activities to establish and ensure compliance with quality systems, quality procedures and policies and regulatory requirements to facilitate compliance with the agencies and customers.
• Provides training for new employees to the QC lab using approved documentation
• Develop, implement and maintain programs and processes to ensure high quality products and compliance with ICH, GMP, GLP and a safe & clean lab operation.
• Help with the maintenance of QC Lab documentation SOP’s, methodology, specifications, calibrations sheets, logbooks, etc. through change control, when needed.
• Lead or participate in focused deviation cross-functional investigations, improvement projects and other initiatives.
• Help identify Continuous Improvement Opportunities and perform their implementation.
• Implement management’s strategies and activities related to assuring compliance with regulations and ensure the company’s data integrity.
• Provide support for QC operations information during agency inspections as requested by QC manager.
• Manage ordering through SAP inventory management system.
• Investigate vendor options; ensure timely ordering procedures for consumable and chemical supplies; establish service contracts (such as for annual preventive maintenance of analytical instruments)
• In process samples testing record review and approval for release, when needed.
• Aid with retains & Stability testing program oversight, when needed.
• Quality systems support, including but not limited to: Investigation Support, Labeling, complaints, document control, training, CAPAs & Annual Product Reviews. When required.
• Participates in product development support, including but not limited to: Methodology Transfers, Stability program, project management, excel validations, oversight of special studies supporting regulatory filings and data/record retrieval for regulatory submissions.
• Prepare protocols, reports, metrics trend reporting, validation, logs & other documentation as needed.
• Help with review of manufacturing batch records.
• Other quality activities in support of the product as necessary & agreed upon.

Qualifications

• Working knowledge of laboratory instrumentation to include GC, ICP-MS, IR, Karl Fischer, PH, UV-VIS, Density, Auto-titration and Refractive Index.
• Experience in analytical method development, method transfer and validation.

• Experience in supporting FDA, EU, Corporate & other regulatory audits.
• Experience in writing SOPs, test methods and reviewing validation protocols in a pharmaceutical manufacturing laboratory environment.
• Experience with deviations, investigations & change controls.
• Proficiency with computer office tools (Word, Excel, LIMS, Outlook & scientific databases, etc.) is required.
• Ability to work in a fast paced environment and manage priorities & maintain timelines for multiple projects is essential.
• Knowledge of ICH, GLP & GMP guidelines & their applications.
• Needs to be highly motivated and flexible, with excellent problem solving skills.
• Advanced verbal, technical writing and interpersonal communication skills.

Education/ Experience

• S. in Chemistry or scientific discipline is required.
• Minimum 3 plus years’ experience working in a pharmaceutical QC manufacturing laboratory environment with emphasis utilizing Gas Chromatography.
• Strong documentation skills.
• Some knowledge of Pharmaceutical regulations & audit experience a plus.